BEUDAMED
    9,662 results · 41ms · Sources: EU EUDAMED, US FDA

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER

    Immunohistochemistry Assay, Antibody, Claudin 18

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·GELFOAM STERILE SPONGE

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·VISX STAR S4 IR EXCIMER LASER SYSTEM

    Programmer, Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

    Intervertebral Fusion Device With Bone Graft, Lumbar

    FDA Pre-Market Approval
    FDA Class 2 ·DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·CARELINK PERSONAL SOFTWARE

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·TECHNOLAS 217A EXCIMER LASER SYSTEM

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

    Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test

    FDA classification
    FDA Class 2 ·Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·REVO MRI SURESCAN IPG AND PACING SYSTEM

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·FOCALPOINT SYSTEMCREENING SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASOSEAL ES AND VHD DEVICES